A Randomized, Cross-over, Open, Euglycemic Clamp Study on the Relative Bioavailability and Activity of 0.6 U/kg Insulin Glargine and 20 μg Lixisenatide, Given as On-site Mix Compared to Separate Simultaneous Injections in Subjects With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Area under the plasma lixisenatide concentration curve (LIX-AUClast)
研究概览
简要总结
Primary Objective:
- to assess the relative bioavailability of a single dose of insulin glargine (Lantus) and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug
Secondary Objectives:
- to compare the activity of a single dose of insulin glargine and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug
- to assess the safety and tolerability of insulin glargine and lixisenatide given subcutaneously as on-site mix
详细描述
The study period for one patient is one month in average and it can last up to 7 months (+ 2 weeks) with post-study and follow-up visits
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lantus(insulin glargine)/lixisenatide on-site mix
Single dose injection of an on site mix of Lantus U100 and lixisenatide (800µg/mL in Lantus U100) at one peri-umbilical site under fasting conditions
干预措施: Insulin glargine HOE901 (Drug)
Lantus(insulin glargine)/lixisenatide on-site mix
Single dose injection of an on site mix of Lantus U100 and lixisenatide (800µg/mL in Lantus U100) at one peri-umbilical site under fasting conditions
干预措施: Lixisenatide AVE0010 (Drug)
lixisenatide + Lantus (insulin glargine)
Single dose, separate injection simultaneous injections of Lantus U100 and lixisenatide (100µg/mL) at opposite peri-umbilical sites within 1 minute under fasting conditions
干预措施: Insulin glargine HOE901 (Drug)
lixisenatide + Lantus (insulin glargine)
Single dose, separate injection simultaneous injections of Lantus U100 and lixisenatide (100µg/mL) at opposite peri-umbilical sites within 1 minute under fasting conditions
干预措施: Lixisenatide AVE0010 (Drug)
结局指标
主要结局
Area under the plasma lixisenatide concentration curve (LIX-AUClast)
时间窗: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Lixisenatide maximum plasma/serum peak concentration (LIX-Cmax)
时间窗: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
次要结局
- Area under the plasma lixisenatide concentration curve (AUC)(1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period)
- Time to Cmax (Tmax ) for lixisenatide(1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period)
- Area under the body weight standardized glucose infusion rate curve (GIR) within 24 h (GIR-AUC0-24)(1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period)
- Time to 50% of the GIR-AUC within 24 h (T50%-GIR AUC0-24)(1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period)
- Maximum smoothed body weight standardized glucose infusion rate GIRmax(1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period)
- Time to GIRmax (GIR-Tmax)(1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period)